Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636539
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-center image case collection study to acquire de-identified contrast-enhanced breast images on the Investigational Device to support continuing technology development Eligible subjects include women at least 35 years old with a suspicious finding or breast abnormality on a screening or diagnostic mammogram who are indicated for a diagnostic exam or a biopsy procedure
Detailed Description:
Contrast-Enhanced Mammography CEM is intended to be an extension for diagnostic mammography with the Investigational Device It is a technique in which digital 2D mammography is supplemented with the use of intravenous iodinated contrast administration to facilitate cancer detection The imaging acquired under a contrast agent has preferential uptake in regions of increased vascularity providing complement information for diagnosis The CEM software application that will be tested is similar to the marketed software I-View 20 and is intended for use as an adjunct following mammography andor ultrasound exams as a diagnostic work-up to localize and further characterize a known or suspected lesion
Thus to assess the clinical efficacy of the CEM imaging acquired in the Investigational Device Sponsor is conducting a prospective case collection study to support the verification and validation of image quality assessments
Thus to assess the clinical efficacy of the CEM imaging acquired in the Investigational Device Sponsor is conducting a prospective case collection study to support the verification and validation of image quality assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None